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Research and human factors
Human Factors is a scientific discipline that applies psychological and physiological principles to the design of products to reduce human error and make sure products are safe.
In healthcare, this involves identifying and mitigating patient and user risk in a systematic way, where risk refers to potential harm to the patient associated with your product.
In practice, this means that in addition to validating that you’re meeting user needs and delivering against requirements, you also use your research findings to identify risks and test the mitigation strategies that you’ve implemented. Integrating this structured way of thinking about patient risk allows you to:
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- Develop a safe product for healthcare and follow good practice for patient safety.
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- Create the basis for human factors documentation, which might be necessary to receive accreditation as a medical device under international standards (e.g. ISO 62366, ISO 13485 or CE marking) to gain access to market.
The risks you identify should be collated and updated in the risk register you created as part of design development planning. These risks need to cover correct and incorrect use of the product in the intended use environment (e.g. patients’ homes or a hospital ward).
How to identify risks in your research
Risks can be identified in a few ways and at several different points in your process.
Known and foreseeable use problems can be a good starting point to identify risks. These are problems associated with the use of similar products to yours.
For example, if your product runs on a tablet, the patient holding the tablet incorrectly and inadvertently pressing a button is a known use problem that others have found. In this example, the outcome would be that the patient selects the wrong option. A mitigation for this could be a prompt to confirm the selected option so there is an opportunity to correct the wrong option.
Formative Research. Insights from usability testing during product development allow you to identify potential risks early on but also help you identify critical tasks, which are related to further risks. If you conduct contextual formative research it will also provide insight into use in relevant environments. You’ll be able to identify risks by assessing the outcome of each finding and how this might impact the patient or user.
Summative Usability Evaluation. In addition to validating whether your design meets your identified user needs, your summative usability evaluation validates whether previously identified risks have been effectively mitigated.
Risks identified as medium or severe should inform the tasks and scenarios you provide users with and the outcome should be documented in the risk register. In this way, you test whether the design features you’ve implemented mitigate risks or whether you need to take further steps such as design changes, user training or use limitations.
Formative vs Summative
As an example of how this might work, let’s say that during formative contextual research one of your findings was that most participants ignore the instructions booklet and straight away turn on their health monitoring device. This might mean that people don’t use the device properly. To mitigate this, you could also display all instructions on the device when it is first turned on.
In your summative usability evaluation you’d then need to evaluate whether users are actually reading the instructions on the screen and therefore whether your mitigation has been successful.